PlainRecalls

2012 Recalls

4,173 recalls · Page 37 of 84

2012 Recall Year Insight

Federal agencies issued 4,173 product recalls indexed by PlainRecalls in calendar year 2012. That represents about 4.10% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 11.4 recalls per day across the FDA, CPSC, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 84 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2012.

On this page of 50 records, severity classification shows 2 critical, 46 moderate, and 2 lower-severity recalls. The page references 34 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (36), FDA Drug (14), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2012 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Oct 3, 2012

Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90

Abbott Laboratories

FDA Drug Moderate Oct 3, 2012

Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.

Abbott Laboratories

FDA Drug Moderate Oct 3, 2012

Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.

Abbott Laboratories

FDA Drug Critical Oct 3, 2012

Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Li…

www.vitaminbestbuy.com

FDA Drug Moderate Oct 3, 2012

Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches …

Actavis

FDA Drug Moderate Oct 3, 2012

Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product co…

Baxter Healthcare Corp.

FDA Drug Moderate Oct 3, 2012

5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E00…

Baxter Healthcare Corp.

FDA Drug Moderate Oct 3, 2012

CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Brac…

Bracco Diagnostics Inc

FDA Drug Low Oct 3, 2012

Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous …

Mallinckrodt Inc

FDA Drug Moderate Oct 3, 2012

5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 6001…

Baxter Healthcare Corp.

FDA Drug Moderate Oct 3, 2012

0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product …

Baxter Healthcare Corp.

FDA Drug Moderate Oct 3, 2012

Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05

Mylan Pharmaceuticals Inc.

FDA Drug Moderate Oct 3, 2012

Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patie…

Hospira Inc.

FDA Drug Critical Oct 3, 2012

Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Labor…

Ben Venue Laboratories Inc

FDA Devices Moderate Oct 3, 2012

Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System design…

Hologic, Inc.

FDA Devices Moderate Oct 3, 2012

Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinfo…

Covidien LP

FDA Devices Moderate Oct 3, 2012

Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 71202…

Philips Healthcare Inc.

FDA Devices Moderate Oct 3, 2012

Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinfo…

Covidien LP

FDA Devices Moderate Oct 3, 2012

Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcem…

Covidien LP

FDA Devices Moderate Oct 3, 2012

BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measure…

OPTI Medical Systems, Inc

FDA Devices Moderate Oct 3, 2012

Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinfo…

Covidien LP

FDA Devices Moderate Oct 3, 2012

Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Oct 3, 2012

***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source

Linvatec Corp. dba ConMed Linvatec

FDA Devices Moderate Oct 3, 2012

Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Nat…

Greatbatch Medical

FDA Devices Moderate Oct 3, 2012

Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinfo…

Covidien LP

FDA Devices Moderate Oct 3, 2012

Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

Abbott Vascular

FDA Devices Moderate Oct 3, 2012

SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTher…

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Oct 3, 2012

Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The …

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Oct 3, 2012

Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed…

Hologic, Inc.

FDA Devices Moderate Oct 3, 2012

Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conj…

Linvatec Corp. dba ConMed Linvatec

FDA Devices Moderate Oct 3, 2012

Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09**…

Cordis Corporation

FDA Devices Moderate Oct 3, 2012

DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System

Imaging Sciences International, LLC

FDA Devices Moderate Oct 3, 2012

Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcemen…

Covidien LP

FDA Devices Moderate Oct 3, 2012

Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Oct 3, 2012

Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40C…

Applied Medical Resources Corp

FDA Devices Moderate Oct 3, 2012

Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal …

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Oct 3, 2012

Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for applicat…

Neomend Inc

FDA Devices Moderate Oct 3, 2012

Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATIO…

Applied Medical Resources Corp

FDA Devices Moderate Oct 3, 2012

Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013…

Cordis Corporation

FDA Devices Moderate Oct 3, 2012

TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device con…

Toshiba American Medical Systems Inc

FDA Devices Low Oct 3, 2012

Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the …

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA Devices Moderate Oct 3, 2012

The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone …

Integra Limited

FDA Devices Moderate Oct 3, 2012

Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Aler…

Alere San Diego, Inc.

FDA Devices Moderate Oct 3, 2012

Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the periphe…

Micro Therapeutics Inc, Dba Ev3 Neurovascular

FDA Devices Moderate Oct 3, 2012

KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant

Mc-NEIL-PPC, Inc.

FDA Devices Moderate Oct 3, 2012

Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individual…

Invacare Corporation

FDA Devices Moderate Oct 3, 2012

BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. …

KCI USA, Inc.

FDA Devices Moderate Oct 3, 2012

Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured…

Varian Medical Systems, Inc. Oncology Systems

FDA Devices Moderate Oct 3, 2012

Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforceme…

Covidien LP

FDA Devices Moderate Oct 3, 2012

This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. Thes…

Alcon Research, LTD.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2012 with 2011 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2012

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2012 across the FDA, CPSC and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.